Pudendal NerveELANEPNCT07458737

Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women

An observational study of Pudendal Nerve and Healthy Women, run by Comenius University at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pudendal Nerve, Healthy Women
What is being tested?: Pelvic floor shear wave elastography, Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) and Female Sexual Distress Scale-Revised (FSDS-R)
How many people: 94 participants
Where: 1 siteSlovakia
Study dates: 15 Mar 2025to 2 Mar 2026
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: Study Population This observational study enrolled adult women (≥18 years) categorized into two cohorts: a pudendal neuralgia (PN) group and a healthy control group. Participants in the PN group were recruited from an outpatient clinic database. Inclusion required a diagnosis of pudendal neuralgia confirmed by a gynecologist according to the Nantes criteria (Labat et al., 2008), including a positive response to an anesthetic pudendal nerve block, and a symptom duration of ≥ 3 months. The healthy control group consisted of volunteers recruited from university staff with no history of chronic pelvic pain or pelvic floor dysfunction.

Who may be able to join

Diagnosis of Pudendal Neuralgia based on the Nantes diagnostic criteria (Labat et al., 2008), specifically:
Pain located in the anatomical territory of the pudendal nerve.
Pain worsened by sitting.
Pain that does not wake the patient at night.
No objective sensory loss on clinical examination.
Positive response to an anesthetic pudendal nerve block.

Show all 12Show fewer

Duration of symptoms: Chronic pelvic pain persisting for more than 3 months.
Demographics: Women aged (≥18 years).
Voluntary participation: Ability to understand and sign informed consent.
Demographics: Women aged (≥18 years).
Asymptomatic status: No history or current symptoms of chronic pelvic pain or pelvic floor dysfunction (confirmed by clinical interview/screening).
Voluntary participation: Signed informed consent.

Who cannot join

Medical Comorbidities: Diagnosed psychiatric, neurological (other than PN), severe internal, orthopedic, or oncological diseases that could interfere with the study outcomes.
Recent Interventions: History of botulinum toxin therapy to the pelvic floor within the last 12 months.
Pelvic surgery within the last 12 months.
Data Integrity: Incomplete or incorrectly filled questionnaires.
General: Unwillingness to participate or inability to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

Comenius University in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia
Martin, Slovakia, 040 22

Other trials in Slovakia

About this study

Official title: Comparison of Superficial Pelvic Floor Shear Wave Elastography Between Healthy Women and Women With Pudendal Neuralgia

This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.

Read the detailed description

Using shear-wave elastography, this study will compare the superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles) between healthy women and women with pudendal neuralgia.

Conditions: Pudendal Nerve, Healthy Women
Being tested: Pelvic floor shear wave elastography, Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7), Female Sexual Distress Scale-Revised (FSDS-R)
Keywords: Pudendal neuralgia, Shear-wave elastography, Healthy women
Medical subject headings: Pudendal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pelvic floor shear wave elastographyDiagnostic test
Imaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view ~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).
Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)Diagnostic test
The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.
Female Sexual Distress Scale-Revised (FSDS-R)Diagnostic test
The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.

Study groups in NCT07458737
Study group	Role	What they receive
Women with Pudendal Neuralgia		Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist. Receives: Diagnostic Test: Pelvic floor shear wave elastography; Diagnostic Test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); Diagnostic Test: Female Sexual Distress Scale-Revised (FSDS-R)
Healthy women		Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction. Receives: Diagnostic Test: Pelvic floor shear wave elastography; Diagnostic Test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); Diagnostic Test: Female Sexual Distress Scale-Revised (FSDS-R)

What is being measured

The primary outcome is the main question the study is designed to answer.

Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
Stiffness of superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, superficial transverse perineal muscles) assessed with SWE; comparison between healthy women and women with pudendal neuralgia. Shell analysis was used to identify and compare two specific locations within each muscle: the site of maximum stiffness (b-site) and the site of minimum stiffness (a-site). The data represent the maximum stiffness measured at the most affected sites in KPa.
Measured: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.

Secondary outcomes (2)

Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
The Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) is a 21-item instrument that assesses the impact of pelvic floor disorders across three domains: bladder (Urinary Impact Questionnaire, UIQ-7), bowel (Colorectal-Anal Impact Questionnaire, CRAIQ-7), and vaginal symptoms (Pelvic Organ Prolapse Impact Questionnaire, POPIQ-7).
Scale Ranges: Each of the three subscales (UIQ-7, CRAIQ-7, and POPIQ-7) is scored from 0 to 100. The PFIQ-7 Total Score is calculated as the sum of these three subscales, ranging from a minimum of 0 to a maximum of 300.
Interpretation: For all subscales and the total score, higher values represent a worse outcome (greater negative impact on quality of life).
Measured: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.
Sexual Distress (FSDS-R Total Score)
Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress.
Measured: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 20252 Mar 2026

First posted9 Mar 2026
Study start15 Mar 2025
Primary completion25 Feb 2026
Study completion2 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pudendal NerveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07458737
Sponsor's protocol ID: 6808/2023/ODDZ
Acronym: ELANEP
Status last verified: Jun 2026
First submitted: 26 Feb 2026
Last updated: 6 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pudendal Nerve trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Superficial Pelvic Floor Shear Wave Elastography Between Healthy Women and Women With Pudendal Neuralgia
ClinicalTrials.gov ID: NCT07458737
Acronym / sponsor ID: ELANEP / 6808/2023/ODDZ
Conditions: Pudendal Nerve, Healthy Women
Keywords: Pudendal neuralgia, Shear-wave elastography, Healthy women
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Comenius UniversityUniversity, hospital or other
Collaborators: Pavol Jozef Safarik University
Study start: 15 Mar 2025 (actual)
Primary completion: 25 Feb 2026 (actual)
Study completion: 2 Mar 2026 (actual)
First posted: 9 Mar 2026 (actual)
Results: Posted 2 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Women with Pudendal Neuralgia	–	Diagnostic Test: Pelvic floor shear wave elastography, Diagnostic Test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7), Diagnostic Test: Female Sexual Distress Scale-Revised (FSDS-R)Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
Healthy women	–	Diagnostic Test: Pelvic floor shear wave elastography, Diagnostic Test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7), Diagnostic Test: Female Sexual Distress Scale-Revised (FSDS-R)Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Study Population This observational study enrolled adult women (≥18 years) categorized into two cohorts: a pudendal neuralgia (PN) group and a healthy control group. Participants in the PN group were recruited from an outpatient clinic database. Inclusion required a diagnosis of pudendal neuralgia confirmed by a gynecologist according to the Nantes criteria (Labat et al., 2008), including a positive response to an anesthetic pudendal nerve block, and a symptom duration of ≥ 3 months. The healthy control group consisted of volunteers recruited from university staff with no history of chronic pelvic pain or pelvic floor dysfunction.

Key inclusion criteria (12 listed)

Diagnosis of Pudendal Neuralgia based on the Nantes diagnostic criteria (Labat et al., 2008), specifically:
Pain located in the anatomical territory of the pudendal nerve.
Pain worsened by sitting.
Pain that does not wake the patient at night.
No objective sensory loss on clinical examination.

Key exclusion criteria (5 listed)

Medical Comorbidities: Diagnosed psychiatric, neurological (other than PN), severe internal, orthopedic, or oncological diseases that could interfere with the study outcomes.
Recent Interventions: History of botulinum toxin therapy to the pelvic floor within the last 12 months.
Pelvic surgery within the last 12 months.
Data Integrity: Incomplete or incorrectly filled questionnaires.
General: Unwillingness to participate or inability to provide informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pelvic floor shear wave elastographyImaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view ~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).	Diagnostic test	Healthy women, Women with Pudendal Neuralgia
Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.	Diagnostic test	Healthy women, Women with Pudendal Neuralgia
Female Sexual Distress Scale-Revised (FSDS-R)The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.	Diagnostic test	Healthy women, Women with Pudendal Neuralgia

Primary outcome

Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
Time frame: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.
Stiffness of superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, superficial transverse perineal muscles) assessed with SWE; comparison between healthy women and women with pudendal neuralgia. Shell analysis was used to identify and compare two specific locations within each muscle: the site of maximum stiffness (b-site) and the site of minimum stiffness (a-site). The data represent the maximum stiffness measured at the most affected sites in KPa.

2 secondary outcomes

Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)
Time frame: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.
Sexual Distress (FSDS-R Total Score)
Time frame: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.

Results and safety

Results posted to the registry on 2 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Women With Pudendal Neuralgia	44	44
Healthy Women	44	44

Primary outcome: Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography

Time frame: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.. Median (Inter-Quartile Range). Unit: kilopascals

Measure	Women With Pudendal Neuralgia n = 44	Healthy Women n = 44
m.bulbospongiosus- right side, b-places with the highest stiffness	612.0 (423.0 to 695.5)	26.5 (23.0 to 167.2)
m.bulbospongiosus- right side, a-places with the lowest stiffness	33.0 (27.2 to 39.0)	21.0 (15.5 to 24.0)
m.bulbospongiosus- left side, b-places with the highest stiffness	572.0 (408.5 to 665.5)	149.0 (39.5 to 330.0)
m.bulbospongiosus- left side, a-places with the lowest stiffness	25.0 (17.2 to 37.5)	23.9 (14.6 to 26.0)
m.ischiocavernosus- right side, b-places with the highest stiffness	324.5 (223.5 to 487.0)	120.0 (51.6 to 158.8)
m.ischiocavernosus- right side, a-places with the lowest stiffness	25.5 (15.8 to 41.5)	15.0 (9.0 to 29.0)
m.ischiocavernosus- left side, b-places with the highest stiffness	305.0 (195.5 to 440.0)	150.0 (72.0 to 168.9)
m.ischiocavernosus- left side, a-places with the lowest stiffness	23.0 (17.0 to 32.8)	21.0 (10.2 to 28.8)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the beginning of the imaging procedure until the end of the clinical assessment (approximately 1 hour per participant).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women With Pudendal Neuralgia	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Healthy Women	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Pudendal Nerve

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Magdalena Hagovska, prof.PhDr.PhD. principal investigator

Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia

Jan Svihra, prof.MUDr.PhD. study director

Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pudendal Nerve and Healthy Women, run by Comenius University at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography (time frame: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07458737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.